Home / Recalls / Med Tec Inc / Z-0671-2018

Z-0671-2018 Class II Terminated

Recalled by Med Tec Inc — Orange City, IA

Recall Details

Product Type
Devices
Report Date
February 28, 2018
Initiation Date
November 8, 2017
Termination Date
August 21, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 installations

Product Description

Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal X, Y, Z and yaw motions to provide 6-degree axis movement. The product includes an interface between the treatment planning system and the treatment table to direct the table motion based on coordinates supplied. These products connect or support a treatment table by use of various mounting plates.

Reason for Recall

When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.

Distribution Pattern

US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.

Code Information

MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.1 (M881920, M880610), MT6XSM1.7.2 (Lot M924170), MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3 (Lot M093990), MT6XSM1.7.3-1, MT6XSM1.7.3-3

Other recalls by Med Tec Inc

  • Z-2243-2020 Class II — Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: (May 12, 2020)
  • Z-1837-2019 Class II — CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 (April 15, 2019)
  • Z-3082-2017 Class II — CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standar (August 10, 2017)
  • Z-3083-2017 Class II — CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Se (August 10, 2017)
  • Z-1992-2016 Class II — Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), (March 31, 2016)
  • Z-2763-2015 Class II — CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged (August 19, 2015)
  • Z-0990-2015 Class II — Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs (December 11, 2014)
  • Z-0989-2015 Class II — Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-ster (December 11, 2014)